Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT06430658
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed sorely ESCC without other histology subtypes.
2. Thoracic esophageal cancer.
3. No prior anti-cancer treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
4. Borderline unresectable locally advanced ESCC deemed by investigators as suspicious of but not confirmed T4b according to the American Joint Committee on Cancer (AJCC) 8th edition staging classification or extracapsular lymph node involvement (ELNI).
5. The Karnofsky Performance Scale (KPS) ≥70.
6. Normal primary organ functions, including but not limited to hemoglobin (Hb) ≥ 100g/L; white blood cell (WBC) ≥ 3.5×10\*9/L; neutrophil count (NEUT) ≥ 1.5×10\*9/L; platelets (PLT) ≥ 100×10\*9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×UNL; total bilirubin (TBIL) ≤ 1.5×UNL; creatinine ≤ 1.5UNL; blood urea nitrogen (BUN) ≤ 1.0×UNL.
Exclusion Criteria:
1. Synchronous and metachronous primary malignancies in but not limited to the upper aerodigestive tract, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
2. Patients have undergone any type of anti-cancer treatment.
3. Baseline clinical stage M1 per AJCC 8th edition of staging classification, including supraclavicular lymph node metastases.
4. Investigators assessed major vessel involvement with high-risk hemorrhage.
5. A higher probability of esophageal perforation during conversion therapy.
6. Active infectious diseases, including but not limited to tuberculosis, hepatitis B virus, or hepatitis C virus.
7. Allergic to anti-cancer agents, including but not limited to anti-PD-1 or chemotherapy agents.
8. Given cardiopulmonary dysfunction, patients can not tolerate conversion therapy or surgery.
9. Pregnant or lactating women and women of childbearing potential who lacked effective contraception.
10. Non-compliance with the inclusion criteria judged by investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06430658
Study Brief:
Protocol Section:
NCT06430658